Study Results
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Basic Information
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RECRUITING
4200 participants
OBSERVATIONAL
2021-09-13
2027-12-31
Brief Summary
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Detailed Description
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The patients will be recruited from 3 hospitals: Oslo University Hospital, Lovisenberg Diakonale Hospital (Oslo) and St Olav Hospital (Trondheim). The recruitment period will be approximately 4 months for the control group and 4 months for the case group, and estimations based on previous admission numbers for the 3 hospitals results in about 2500 patients in each group.
For the study, research personnel will approach the eligible patients once they have been admitted to various medical wards. The personnel will give the patients written and verbal information about the study, and the patients who agree to be part of the study will sign a written consent. Baseline data will be recorded for all patients included in the control and case groups. These data include:
* Alcohol use past 12 months, Alcohol Use Disorder Identification Test (AUDIT-4)
* Alcohol use last 24 hours,
* Stages-of-change questionnaire on alcohol, psychoactive medicinal and/or illicit drug use past 12 months,
* Non-prescribed use of psychoactive medicinal drugs past 12 months
* Drug Use Disorder Identification Test (DUDIT)
* Stages-of-change questionnaire on psychoactive medicinal drugs or illicit drugs
* Symptoms Checklist (SCL-5)
* Left-over blood samples used for routine diagnostic testing will be collected and analyzed for ethanol, phosphatidylethanol (PEth; biomarker for alcohol use last 3 weeks), diazepam, N-desmethyldiazepam, clonazepam, oxazepam, nitrazepam, alprazolam, zopiclone, zolpidem, morphine, codeine, oxycodone, buprenorphine, methadone, tramadol, amphetamine, methamphetamine, ecstasy (MDMA), THC, cocaine and benzoylecgonine.
* Patients in the case group will be invited to submit a new blood sample for PEth analysis 2 months after inclusion.
* After 12 months, baseline data will be coupled to the following data from the patient journal: date and time of admission, days and hours spent at bed-post and intensive care, number of previous hospital admissions, ICD-10 diagnoses at discharge, level of care, AUDIT-C score, ethanol and PEth concentration in blood, psychoactive medicine concentration in serum, CIWA-Ar, Glasgow Coma Scale (GCS) score, first triage at hospital, medicinal curve at admission, marital status, employment status, care status for children under 18 years of age. Data will also be coupled to various registry data; The Norwegian Patient Registry: number of admissions in the specialist health care service 5 years prior to admission, number of treatments with main diagnosis from ICD-10 the within 5 years prior to admission, number of admissions to interdisciplinary specialist treatment within 5 years after admission, number of admissions within 5 years after admission; The Social Security Database: performance status at time of admission and 1 year after; The Norway Control and Payment of Health Reimbursement (KUHR) Database and the Norwegian Registry for Primary Health Care: patients use of institutions and other primary health care services such as home nursing and nursing homes 5 years prior to and 5 years after admission, overview of drug use diagnoses; the Norwegian Prescription Registry: medication prescribed 5 years prior to and 5 years after admission; and the Cause of Death Registry: cause of death within 5 years after admission.
The database from baseline (questionnaires and blood sample analysis), patient journal data and the various registry data collected from each included patient will be treated de-identified. The questionnaires will be in an online-format ("Nettskjema"), and the data will be submitted directly in a secure database provided by the University of Oslo, called Services for Sensitive Data (short form "TSD" in Norwegian).
In the final database, missing values in variables will result in exclusion of that patient in statistical analysis (when the variable with missing value is part of a specific analysis). Statistical analyses will include:
For the alcohol intervention:
* To control for baseline measures, multiple models for repeated measures will be used to evaluate anticipated differences between the intervention and the control groups. For the continuous outcomes (number of admissions and GP visits) linear mixed models will be fitted, for binary outcomes models with log link or Poisson link function will be used.
For the psychoactive medicinal drug intervention:
* Multiple mixed effects models for repeated measures will be fitted. The three different institutions will be entered as random effects, while selected covariates as patients' age and gender will be modeled as fixed effects. Continuous outcomes (serum concentrations) will be analyzed using linear mixed models, while changes in prescriptions with the outcome being binary will be modeled using mixed models with log or Poission link function. The results will be expressed as effect sizes (for linear models) or relative risks (RR) for models of binary outcomes.
Conditions
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Study Design
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CASE_CONTROL
PROSPECTIVE
Study Groups
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Control group
2500 participants will be recruited before the intervention procedures are implemented at the respective hospitals. Baseline data on alcohol, psychoactive medicinal and illicit drug use (AUDIT-4 and DUDIT), stages-of-change questionnaire on alcohol, medicinal drugs and illicit drug use, and mental distress will be recorded. Left-over full blood from routine diagnostic testing will be collected and analyzed for alcohol biomarkers (ethanol and phosphatidylethanol (PEth)) and psychoactive medicinal and illicit drugs. The participants in the control group will receive acute medical treatment according to hospital procedures. After 12 months, the data from baseline will be coupled to data from patient journals and data from relevant registries.
No interventions assigned to this group
Case group
2500 participants will be recruited after the intervention procedures are implemented. Baseline data on alcohol, psychoactive medicinal and illicit drug use, stages-of-change questionnaires, and mental distress will be recorded. Left-over blood from diagnostic testing will be collected and analyzed for alcohol biomarkers (ethanol and phosphatidylethanol (PEth)) and psychoactive medicinal and illicit drugs. The participants in the case group will receive treatment according to new hospital procedures, including screening for harmful alcohol use and non-prescribed use of psychoactive medicinal drugs and intervention. If feasible, a new blood sample will be collected 2 months after inclusion, which will be analyzed for PEth. After 12 months, the data from baseline will be coupled to patient journals and relevant registries.
Harmful alcohol use treatment
Patients identified through routine hospital screening as having a potentially harmful alcohol use (AUDIT-C 4-6 points (men) / 3-5 points (women) will receive information about the possible harmful effects of their drinking and will be advised to reduce their consumption. Patients identified with more excessive drinking patterns (AUDIT-C \> 6 (men) / \> 5 (women) will be assessed with blood sample analysis of relevant alcohol biomarkers, psychological assessments for alcohol addiction and withdrawal symptoms, and if necessary referral to alcohol addiction treatment. Patients with severe withdrawal symptoms will be put in CIWA-Ar observation.
Non-prescribed psychoactive medicinal use treatment
Patients with prescription on psychoactive medicinal drugs are pharmacologically assessed using serum sample analysis. Patients identified with discrepancy in prescribed doses and serum concentrations will have doses adjusted, or be referred to addiction treatment. Patients identified with psychoactive medicinal drugs other than those prescribed will be advised to quit those medications, or be referred to addiction treatment.
Interventions
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Harmful alcohol use treatment
Patients identified through routine hospital screening as having a potentially harmful alcohol use (AUDIT-C 4-6 points (men) / 3-5 points (women) will receive information about the possible harmful effects of their drinking and will be advised to reduce their consumption. Patients identified with more excessive drinking patterns (AUDIT-C \> 6 (men) / \> 5 (women) will be assessed with blood sample analysis of relevant alcohol biomarkers, psychological assessments for alcohol addiction and withdrawal symptoms, and if necessary referral to alcohol addiction treatment. Patients with severe withdrawal symptoms will be put in CIWA-Ar observation.
Non-prescribed psychoactive medicinal use treatment
Patients with prescription on psychoactive medicinal drugs are pharmacologically assessed using serum sample analysis. Patients identified with discrepancy in prescribed doses and serum concentrations will have doses adjusted, or be referred to addiction treatment. Patients identified with psychoactive medicinal drugs other than those prescribed will be advised to quit those medications, or be referred to addiction treatment.
Eligibility Criteria
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Inclusion Criteria
Exclusion Criteria
* Cognitive or mental inability to consent to participation
* Injury or planned surgery as primary reason for admission
18 Years
ALL
Yes
Sponsors
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St. Olavs Hospital
OTHER
Lovisenberg Diakonale Hospital
OTHER
Oslo Municipality
OTHER_GOV
Oslo University Hospital
OTHER
Responsible Party
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Stig Tore Bogstrand
Head of Research
Locations
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Oslo University Hospital
Oslo, , Norway
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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31052
Identifier Type: -
Identifier Source: org_study_id
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